RecruitingNot ApplicableNCT07099885

Simple Urine Composition-based Personalized Algorithm for Effective Congestion Relief in Decompensated Heart Failure


Sponsor

Wroclaw Medical University

Enrollment

90 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this study is to evaluate the effectiveness of loop diuretic adaptative algorithm that is based on machine learning, urine output prediction tool, in decongestion of acute heart failure patients. A total of 90 patients will be enrolled in the study. Of these, 45 will be assigned to the algorithm-based intervention group, while the remaining 45 will serve as the control group. In the control group, all decisions regarding diuretic therapy will be made solely by the attending physician, without the use of the algorithm. Patients will receive intravenous furosemide, with the initial dose determined by the attending physician. Two hours after administration of the diuretic, a spot urine sample will be collected to measure sodium and creatinine concentrations. Based on these values, the 6-hour urine output will be estimated using the machine learning, urine output prediction tool (http://diuresis.umw.edu.pl). This estimate will guide the diuretic therapy plan for the first 24 hours of hospitalization. On the second day, the procedure will be repeated using the same methodology.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized algorithm that uses the content of a patient's urine to guide how much diuretic (water pill) to give people who are hospitalized for a flare-up of heart failure with fluid buildup. The goal is to relieve congestion (swelling, breathlessness) more effectively and safely. **You may be eligible if...** - You are 18 or older - You were admitted to hospital mainly because of a heart failure flare-up with significant leg swelling or fluid buildup - Your NT-proBNP blood test is above 1,500 pg/mL (a marker of heart strain) - You can be enrolled within the first 24 hours of hospitalization - You are expected to need diuretic treatment for at least 48 hours **You may NOT be eligible if...** - You have end-stage kidney disease requiring dialysis - Your blood pressure or heart is unstable and requires medications to keep you alive (inotropes) - You have an active infection requiring intravenous antibiotics Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTStandard of Care (SOC)

Diuretic treatment per attending physician.

DIAGNOSTIC_TESTAlgorithhm-based decongestion

Patient will receive standarized furosemide dosing based on the result of the algorithm-estimated 6h urine output (profiles of diuretic response).


Locations(2)

Wroclaw Medical University

Wroclaw, Dolnosląskie, Poland

Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, Poland

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NCT07099885


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